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ArTiMist™ Clinical Trial Results By Mr Calvin Ross Sofitel Wentworth Hotel Sydney 14 April 2008 Eastland Medical Systems Ltd.

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Presentation on theme: "ArTiMist™ Clinical Trial Results By Mr Calvin Ross Sofitel Wentworth Hotel Sydney 14 April 2008 Eastland Medical Systems Ltd."— Presentation transcript:

1 ArTiMist™ Clinical Trial Results By Mr Calvin Ross Sofitel Wentworth Hotel Sydney 14 April 2008 Eastland Medical Systems Ltd

2 Eastland Medical Systems Norwich Facility

3 Eastland Medical Systems Norwich Facility

4 Eastland Medical Systems Norwich Facility

5 Eastland Medical Systems Facility Norwich Facility

6 Eastland Medical Systems Malaria Focus-Mission   Produce a Product suitable for the treatment of Malaria in Infants and Young Children   To conduct Studies in South Africa and Malaysia   To conduct Clinical trials in Africa and Asia   To Produce a Stable Commercial Product

7 Eastland Medical Systems Malaria Facts  500 million cases reported annually  200 million of these are children  Most deaths in Children are aged “Under 5.”  Most Deaths in Africa!  Over 40% of the planet population exposed  Malaria on the increase due to global changes in weather and temperature

8 Eastland Medical Systems Malaria Reality in Infants  Fever  Dehydration  Vomiting  Diarrhoea  Poor nutrition  Comatose  Death

9 Eastland Medical Systems Current Treatments 1.Oral Tablets and Syrups 2.Injections 3.Suppository 4.ACT’s or Combined Treatments 5.Others

10 Eastland Medical Systems Sublingual Spray Product  Multi dose pack  50 dose pack  Approved Materials  Api (DMF in place)  Analytical methods in place  Stable formulation

11 Eastland Medical Systems Sublingual Advantage - ArTiMist™ Main Points  Easy to administer  No drug to swallow  Rapid absorption  Avoids first pass effect  Single multi dose pack  Can be used in remote areas  Simple training required  Easy to store  Improved bio availability ?

12 Eastland Medical Systems Manufacture of Product  Phase I material will be manufactured in Licensed premises in the UK  Clinical phase manufacture UK  Commercial phase UK & Germany  Full production Germany

13 Eastland Medical Systems Phase I studies  Clinical studies: Conducted in South Africa and Malaysia  Single dose study in Malaysia and a multi dose study in South Africa  Clinics located in both regions  Completed March 2008

14 Eastland Medical Systems Phase I Study Results  A Phase I open labelled Randomized trial to determine the Pharmacokinetics, bioequivalence and relative bio availability of Artemether when administrated as a 3mg/actuation sublingual spray, 6mg/actuation sublingual spay and oral tablets in 16 healthy male subjects.  Results showed the sublingual route has higher bio availability when compared to the oral route.  Artemether sublingual spray 3mg strength and 6mg strength are equivalent when given at the same total dose.  Cmax of Artemether and Dihydroartemisinin has proven dose proportionality.  Overall, Artemether delivered as a sublingual spray is as safe and as well tolerated as the oral route.

15 Eastland Medical Systems Clinical Programme Requirement  Regulatory – Technical Brief  Trial requirements in a single/multi dose study  Phase I - 32 subjects  Phase III – 300 patients  Toxicity data exists (in public domain) 1. Literature only required 2. No further animal studies 3. Local toleration study required  Pump spray delivery system  Back up requirements in place  Drug Master File in place

16 Eastland Medical Systems The Conclusion for ArTiMist™  Superior to Tablet Formulation  Stable Formulation  Dose Proportional  No side effects during trials  Fit For Purpose !


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